Abstract
Abstract Introduction/Background Upadacitinib is an oral Janus kinase inhibitor approved to treat moderate-to-severe atopic dermatitis (AD). While clinical trials have demonstrated its efficacy in treating the signs and symptoms of AD, less is known about its effectiveness in a real-world setting. Objectives This cross-sectional study describes the real-world clinical and patient-reported outcomes of adults with AD enrolled in the CorEvitas AD Registry and treated with upadacitinib for at least four or more weeks. Methods The CorEvitas AD Registry is a prospective, non-interventional registry of adults diagnosed with AD by a dermatologist or qualified dermatology practitioner. The current analysis included participants enrolled between July 21, 2020 through August 7, 2023 who were treated with upadacitinib for at least 4 weeks at the time of evaluation by their provider. Outcome measures included assessments of: skin clearance (Validated Investigators Global Assessment Scale for Atopic Dermatitis [vIGA-AD™], Eczema Area and Severity Index [EASI]); worst itch in the past 24 hours (Peak Pruritus Numeric Rating Scale [PP-NRS]); symptom frequency (Patient-Oriented Eczema Measure [POEM]); quality of life (Dermatologic Life Quality Index [DLQI]); and disease control (Atopic Dermatitis Control Tool [ADCT]). Outcomes were cross-sectionally summarized using data collected at the latest registry visit (Overall cohort), as well as 1 to less than 5 months (1-5 months) and 5-9 months following upadacitinib initiation (Month 1-5 cohort and Month 5-9 cohort, respectively). Subgroup analyses were also conducted based on prior use of biologics indicated for AD (bio-naïve, bio-experienced). Data were analyzed as observed with no imputation. Safety events were not assessed in this analysis. Results A total of 335 patients (mean age 45.6 years; 51.6% female; 64.2% White) were treated with upadacitinib (15 mg: n=221 [70.8%]; 30 mg: n=91 [29.2%]; median treatment duration: 6.9 months). Some patients reported concomitant use of topical corticosteroids (28.1%) and prior use of biologics indicated for AD (dupilumab: 45.4%; tralokinumab: 6.0%). For the Overall cohort, 57.3% had clear or almost clear skin (vIGA-AD 0/1). An EASI ≤3 was observed in 74.8% of patients and 45.3% reported no/minimal itch (PP-NRS 0/1); 40.9% had both EASI ≤3 and PP-NRS 0/1. Most patients (69.3%) reported that their AD was controlled (ADCT <7), 36.4% reported clear or almost clear disease (POEM 0–2), and 39.8% reported no impact of AD on their quality of life (DLQI 0/1). Similar results were observed for the Month 1-5 (n=144) and Month 5-9 (n=194) cohorts; results in bio-naïve and bio-experienced patients were comparable. Conclusions More than half of patients with ≥4 weeks of upadacitinib treatment had clear or almost clear skin and greater than two-thirds reported controlled disease, with similar results observed in both bio-naïve and bio-experienced patients. Over a third reported no/minimal symptom and disease burden. These findings suggest that low levels of disease severity are observed with real-world use of upadacitinib. Future analyses will aim to report changes in disease severity and burden due to persistent upadacitinib treatment.
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